EP1921978A2 - A system, tools, devices and a program for diabetes care - Google Patents
A system, tools, devices and a program for diabetes careInfo
- Publication number
- EP1921978A2 EP1921978A2 EP06775176A EP06775176A EP1921978A2 EP 1921978 A2 EP1921978 A2 EP 1921978A2 EP 06775176 A EP06775176 A EP 06775176A EP 06775176 A EP06775176 A EP 06775176A EP 1921978 A2 EP1921978 A2 EP 1921978A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- glucose
- carbohydrate
- preprandial
- insulin
- postprandial
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 206010012601 diabetes mellitus Diseases 0.000 title abstract description 22
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 251
- 239000008103 glucose Substances 0.000 claims abstract description 251
- 230000000291 postprandial effect Effects 0.000 claims abstract description 63
- 230000000694 effects Effects 0.000 claims abstract description 43
- 238000000034 method Methods 0.000 claims abstract description 5
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims description 119
- 239000008280 blood Substances 0.000 claims description 84
- 210000004369 blood Anatomy 0.000 claims description 84
- 229940125396 insulin Drugs 0.000 claims description 65
- 102000004877 Insulin Human genes 0.000 claims description 64
- 108090001061 Insulin Proteins 0.000 claims description 64
- 238000005259 measurement Methods 0.000 claims description 63
- 150000001720 carbohydrates Chemical class 0.000 claims description 45
- 230000001225 therapeutic effect Effects 0.000 claims description 33
- 238000012544 monitoring process Methods 0.000 claims description 22
- 235000012054 meals Nutrition 0.000 claims description 11
- 238000002560 therapeutic procedure Methods 0.000 claims description 6
- 238000004458 analytical method Methods 0.000 claims description 4
- 210000001519 tissue Anatomy 0.000 claims description 4
- 230000001419 dependent effect Effects 0.000 claims description 3
- 210000001124 body fluid Anatomy 0.000 claims description 2
- 239000010839 body fluid Substances 0.000 claims description 2
- 238000011156 evaluation Methods 0.000 claims description 2
- 210000003722 extracellular fluid Anatomy 0.000 claims description 2
- 238000004590 computer program Methods 0.000 claims 8
- 230000012666 negative regulation of transcription by glucose Effects 0.000 claims 3
- 239000000969 carrier Substances 0.000 claims 1
- 235000014633 carbohydrates Nutrition 0.000 description 29
- 208000013016 Hypoglycemia Diseases 0.000 description 11
- 230000002218 hypoglycaemic effect Effects 0.000 description 9
- 238000004364 calculation method Methods 0.000 description 7
- 201000001421 hyperglycemia Diseases 0.000 description 6
- 238000010586 diagram Methods 0.000 description 5
- 235000013305 food Nutrition 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 150000002303 glucose derivatives Chemical class 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012806 monitoring device Methods 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012502 risk assessment Methods 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
- A61B5/743—Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7271—Specific aspects of physiological measurement analysis
- A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
- A61B5/7445—Display arrangements, e.g. multiple display units
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
Definitions
- the system or tool has been developed to evaluate the effects and the clinical relevance of the margins of error of parameters affecting glucose. It is based on a diabetes treatment concept aimed at normoglycemia after meals by preprandial injections of insulin.
- the system or tool includes as parameters: a) preprandial measurement, b) effect of carbohydrate portions (CARB-P) on maximum glucose increase, c) patient estimate of carbohydrate amounts in food, d) effect of insulin on maximum glucose decrease, e) insulin dosage.
- the device is a portable device and provided for measuring the blood glucose value of a patient.
- the device or method is preferably adapted to display results or advice in a first measurement range or several first measurement ranges despite the measurement error and adapted to inhibit the display of results or advice or display results or advice in a different mode in a second measurement range or in several measurement ranges depending on the measurement error.
- the display may be on the device or separate therefrom and being in wire or wireless connection with the device.
- the device may comprise at least one movement sensor and the display may be activated or inhibited dependent on a signal from the movement sensor.
- the device has preferably incorporated therein a system or tool or program according to the main claims .
- Figure 1 shows parts of a screenshot of a first embodiment of the inventions-
- Figure 2 shows a list of the parameters of the system or tool according to this embodiment of the invention;
- Figure 3 shows a table of the margins of error for the parameters of Figure 2;
- Figure 6 shows another diagram as in Figure 5 with an error of 12% for the self-monitored blood glucose
- Figure 7 shows a diagram as in Figure 5 but with an error of +25%
- Figure 9 shows a table of parameter errors leading to critical point in postprandial blood glucose
- Figure 10 shows a known error grid model for judging acceptance of measurement errors
- Figure 11 shows a new error grid model based on the present invention
- Figure 1 shows a screenshot of a preferred embodiment of the invention.
- the invention can be embodied as a system, a tool, a device, in particular a glucose meter, or as a program. All these embodiments are encompassed when the invention is explained in the following and sometimes called as Diabetes Error Test Model (DETM) .
- DETM Diabetes Error Test Model
- parameters will be either measured directly, such as preprandial blood glucose or be entered via input means on the device or being stored beforehand.
- the parameters shown in Figures 1 and 2 are: a) The pre- prandial blood glucose (BG) being in the range of 30mg/dl to 330mg/dl which has actually been measured preprandial by a device for self-monitoring of blood glucose, for example with a strip blood glucose meter; b) the variability or effect of a carbohydrate portion, giving the blood glucose increase in mg/dl of one carbohydrate portion and being settable between 20mg/dl and 80mg/dl; c) the amount of carbohydrate portions the patients aims or estimates to eat (C-P) with a value of 1 to 5; d) the variability or effect of the insulin, giving the blood glucose decrease in mg/dl for a unit of insulin and being settable between 30mg/d
- C-P the variability or effect of the insulin
- BG (mg/dI) ⁇ 40 40-60 61-120 121-160 161-200 201-240 241-300 301-360
- the 0% error line is additionally shown which is usually not the case, so that the preferred display shows only measured pre-prandial blood glucose values on the horizontal x-axis and calculated postprandial blood glucose values on the lefthand vertical y-axis.
- FIG. 10 shows the EGA as known. [Joan L.Parkes, Scott Pardo, Stephen 1. Slatin, Barry H. Ginsberg, "A new consensus Error Grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose", Diabetes Care, VoI 23, No. 8, pages 1143-1148, August 2000] .
- the system, tool and program offers the option of calculating both EAA and EGA as shown in Figure 13: In this calculation it can be seen that 9% of the points are outside the acceptance range. Interestingly, no point is outside zone A of the EGA. This means, that according to the EGA, this measurement device is perfect, according to the EAA it is unusable.
- the EGA can be painted into the EAA as shown to provide an optical visualization. Notes and considerations: the DETM and treatment algorithms are calibrated to whole blood.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Biophysics (AREA)
- Veterinary Medicine (AREA)
- Physics & Mathematics (AREA)
- Epidemiology (AREA)
- Primary Health Care (AREA)
- Computer Vision & Pattern Recognition (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Signal Processing (AREA)
- Radiology & Medical Imaging (AREA)
- Psychiatry (AREA)
- Physiology (AREA)
- Artificial Intelligence (AREA)
- Databases & Information Systems (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Data Mining & Analysis (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DK10011427.1T DK2260757T3 (en) | 2005-09-09 | 2006-09-08 | System tools, apparatus and a program for diabetes treatment |
EP10011427.1A EP2260757B1 (en) | 2005-09-09 | 2006-09-08 | A system, tools, devices and a program for diabetes care |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CH14682005 | 2005-09-09 | ||
PCT/CH2006/000483 WO2007028271A2 (en) | 2005-09-09 | 2006-09-08 | A system, tools, devices and a program for diabetes care |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP10011427.1A Division EP2260757B1 (en) | 2005-09-09 | 2006-09-08 | A system, tools, devices and a program for diabetes care |
EP10011427.1 Division-Into | 2010-09-29 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1921978A2 true EP1921978A2 (en) | 2008-05-21 |
EP1921978B1 EP1921978B1 (en) | 2012-08-01 |
Family
ID=37836183
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06775176A Active EP1921978B1 (en) | 2005-09-09 | 2006-09-08 | Device and program for diabetes care |
EP10011427.1A Active EP2260757B1 (en) | 2005-09-09 | 2006-09-08 | A system, tools, devices and a program for diabetes care |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP10011427.1A Active EP2260757B1 (en) | 2005-09-09 | 2006-09-08 | A system, tools, devices and a program for diabetes care |
Country Status (9)
Country | Link |
---|---|
US (2) | US7766831B2 (en) |
EP (2) | EP1921978B1 (en) |
JP (1) | JP2009506852A (en) |
CN (1) | CN101257840B (en) |
CA (1) | CA2621556A1 (en) |
DK (1) | DK2260757T3 (en) |
ES (1) | ES2575660T3 (en) |
HK (1) | HK1124502A1 (en) |
WO (1) | WO2007028271A2 (en) |
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US7885698B2 (en) | 2006-02-28 | 2011-02-08 | Abbott Diabetes Care Inc. | Method and system for providing continuous calibration of implantable analyte sensors |
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US8583205B2 (en) * | 2008-03-28 | 2013-11-12 | Abbott Diabetes Care Inc. | Analyte sensor calibration management |
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